A Safety and Feasibility Study of the FARAPULSE Endocardial Ablation System to Treat Paroxysmal Atrial Fibrillation

Not Applicable

Completed

Conditions: Paroxysmal Atrial Fibrillation

Interventions: Device: FARAPULSE Endocardial Ablation System

Registration Number: NCT03714178

Lead Sponsor: Farapulse, Inc.

Brief Summary: PEFCAT is a prospective, single-arm, multi-center, safety and feasibility study evaluating the FARAPULSE Endocardial Ablation System for the treatment of paroxysmal atrial fibrillation.

Detailed Description: Patients undergoing catheter ablation for paroxysmal atrial fibrillation will be screened for enrollment per protocol inclusion and exclusion criteria. Enrolled patients will then undergo ablation using the FARAPULSE Endocardial Ablation System. Subjects will be followed at 7 days, 30 days, 75 days, 6 months, and 12 months with a blanking period for recurrent atrial fibrillation or atrial tachycardia of 3 months following the PEF (pulsed electric field) catheter ablation procedure.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 71

Inclusion Criteria

Patients with documented drug resistant symptomatic PAF who have:
1. Confirmed AF: Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor, implanted devices, telemetry strip or similar, recorded within one year prior to enrollment and showing at least 30 seconds of AF.
2. Frequent AF, defined as ≥ 2 episodes within 6 months of enrollment.
3. Failed AFD, meaning therapeutic failure of at least one antiarrhythmic drug (AFD; class I - IV) for efficacy and / or intolerance
Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.
Patient participation requirements:
1. Lives locally
2. Is willing and capable of providing Informed Consent to undergo study procedures
3. Is willing to participate in all examinations and follow-up visits and tests associated with this clinical study.

Exclusion Criteria

Use of amiodarone within 3 months prior to enrollment
Atrial fibrillation that is any of the following
1. Persistent (by diagnosis or duration > 7 days)
2. Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes
3. Requires ≥ 3 cardioversions in the preceding 12 months
Cardiac anatomical exclusions by imaging within 3 months prior to enrollment:
1. Left atrial anteroposterior diameter ≥ 5.0 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
2. Left ventricular ejection fraction ≤ 40% as documented by TTE
Any of the following cardiac procedures, implants or conditions:
1. Clinically significant arrhythmias other than AF
2. Hemodynamically significant valvular disease
3. Prosthetic heart valve
4. NYHA Class III or IV CHF
5. Previous endocardial or epicardial ablation or surgery for AF
6. Atrial or ventricular septal defect closure
7. Atrial myxoma
8. Left atrial appendage device or occlusion
9. Pacemaker, ICD or CRT
10. Significant or symptomatic hypotension
11. Bradycardia or chronotropic incompetence
12. History of pericarditis
13. History of rheumatic fever
Any of the following within 3 months of enrollment:
1. Myocardial infarction
2. Unstable angina
3. Percutaneous coronary intervention
4. Heart surgery including coronary artery bypass grafting
5. Heart failure hospitalization
6. Stroke or TIA
7. Clinically significant bleeding
8. Pericarditis or pericardial effusion
9. Left atrial thrombus
History of blood clotting or bleeding abnormalities.
Contraindication to, or unwillingness to use, systemic anticoagulation
Contraindications to CT or MRI
Sensitivity to contrast media not controlled by premedication
Women of childbearing potential who are pregnant, lactating or not using birth control
Serious or untreated medical conditions that would prevent participation in the study, interfere with assessment or therapy, or confound data or its interpretation, including but not limited to
1. Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
2. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea
3. Chronic renal insufficiency of < 60 mL/min/1.73 m2, any history of renal dialysis, or history of renal transplant
4. Active malignancy or history of treated cancer within 24 months of enrollment
5. Clinically significant gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux
6. Clinically significant infection
7. Predicted life expectancy less than one year
Clinically significant psychological condition that in the investigator's opinion would prohibit the subject's ability to meet the protocol requirements
Current or anticipated enrollment in any other clinical study

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FARAPULSE Endocardial Ablation	FARAPULSE Endocardial Ablation System	Subjects who are treated with the FARAPULSE Endocardial Ablation System for paroxysmal atrial fibrillation.

Primary Outcome Measures

Name	Time	Method
The Primary Safety Endpoint for This Study is the Composite Safety Endpoint (CSE) Defined as the Proportion of Patients With Early-onset and Late-onset Serious Adverse Events (SAEs) Which Are Device- or Procedure-related.	30 days~12 Months	Early onset (within 30 days of any endocardial ablation for atrial fibrillation). Occurrence of any one of the below events will qualify a subject as a safety failure. * Death * Myocardial infarction (MI) * Persistent diaphragmatic paralysis * Stroke or transient ischemic attack (TIA) * Peripheral or organ thromboembolism * Pericarditis * Cardiac tamponade / perforation * Vascular access complications * Hospitalization (initial or prolonged)\* * Heart block * Late onset (any time during follow-up) * Pulmonary vein (PV) stenosis (\> 70% diameter reduction from baseline) * Atrio-esophageal fistula \* Excludes hospitalization (initial \& prolonged) solely due to arrhythmia (AF/Atrial Flutter/Atrial Tachycardia) recurrence or due to non-urgent cardioversion (pharmacological or electrical).

Secondary Outcome Measures

Name	Time	Method
Feasibility: Pulmonary Vein Isolation	1 Day (Acute)	The proportion of subjects that achieve Acute Procedural Success (APS) defined as the percutaneous endocardial creation of a complete, electrically isolating set of lesions around the ostia of the pulmonary veins (PVI) using the FARAPULSE Endocardial Ablation System during the first procedure, as clinically assessed by entrance and/or exit block performed ≥ 20 minutes after the last PVI lesion is made.